MalfunctionKOD
DOVER
Received May 15, 2026
Report 1423537-2026-00159 · MDR key 25191248
Device
Generic name
Catheter, Urological
Manufacturer
Cardinal Health 200, LlcModel number
1616Catalog number
1616
Lot number
3304U12QX
Product problems
- Unintended Deflation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT BEFORE INSERTING IT INTO THE PATIENT, WATER WAS INJECTED TO INFLATE THE BALLOON; HOWEVER, WATER LEAKED FROM THE BALLOON SECTION. THE DEFECT WAS IDENTIFIED PRIOR TO INSERTION INTO THE PATIENT, SO ONLY WATER WAS USED DURING THE TEST. THERE WAS NO PATIENT USE.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.